Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:06 PM
Study NCT ID:
NCT07334418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-15
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018681', 'term': 'Anesthetics, General'}, {'id': 'D018686', 'term': 'Anesthetics, Intravenous'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consent', 'timeFrame': 'From hospital admission through day of delivery', 'description': 'Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients meeting all inclusion criteria out of all screened', 'timeFrame': 'From hospital admission through day of delivery', 'description': 'Percentage of patients meeting all inclusion criteria out of all screened'}, {'measure': 'Randomization', 'timeFrame': 'From hospital admission through day of delivery', 'description': 'Percentage of consenting patients who undergo study randomization'}, {'measure': 'Quality of postoperative recovery', 'timeFrame': 'Postoperative day 0, 1, 2, or 3', 'description': 'Quality of postoperative recovery via 11-item Obstetric Quality of Recovery Scoring Tool minimum score 0 and maximum score 110. A higher score means better.'}, {'measure': 'Satifaction with anesthesia', 'timeFrame': 'Postoperative day 0, 1, 2, or 3', 'description': 'Satisfaction with anesthesia care via 11-item Obstetric Quality of Recovery Scoring Tool minimum score 0 and maximum score 110. A higher score means better.'}, {'measure': 'Severity and duration of pain', 'timeFrame': 'Postoperative day 0, 1, 2, or 3', 'description': 'Reported severity and duration of pain during surgery via 5-item SONAR (Snapshot Obstetric Anesthesia National Research Project) Maternal Comfort Scale. Minimum score 5 and Maximum score 35. A higher score means better.'}, {'measure': 'Adverse events', 'timeFrame': 'Randomization through postoperative day 30', 'description': 'Postoperative serious adverse events via chart review'}, {'measure': 'Length of stay', 'timeFrame': 'Randomization through postoperative day 30', 'description': 'Post-randomization hospital length of stay via chart review'}, {'measure': 'Need for intensive care', 'timeFrame': 'Randomization through postoperative day 30', 'description': 'Need for maternal intensive care via chart review'}, {'measure': 'New PTSD (Posttraumatic Stress Disorder) symptoms', 'timeFrame': 'Postoperative 6 week', 'description': 'New PTSD (Posttraumatic Stress Disorder) symptoms at 6 weeks after delivery via PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) Minimum score 0 and maximum score 80. A higher score means worse.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Section', 'Delivery; Trauma', 'C-section', 'PTSD'], 'conditions': ['Cesarean Section', 'Delivery; Trauma']}, 'descriptionModule': {'briefSummary': 'Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after pregnancy. Currently, the two main options for treating this pain are general anesthesia (full medically induced unconsciousness) and using intravenous medications to reduce the pain and decrease anxiety. The EAGLET-CS Pilot is a pilot randomized trial that will test the feasibility of comparing the impact of these two options for preventing PTSD in a rigorous way for those patients who experience pain during their cesarean section after the baby is out.', 'detailedDescription': 'The EAGLET-CS Pilot is a randomized trial that will assess the feasibility of comparing two commonly used approaches to care for women undergoing cesarean delivery under standard neuraxial anesthesia (epidural, spinal, or CSE) who experience intraoperative pain after delivery that is refractory to first line treatments. 12 patients recruited from the labor and delivery service at the Hospital of the University of Pennsylvania will be assigned to one of two standard-care comparators, namely early conversion to general anesthesia versus a time-limited trial of intravenous sedation, followed by conversion to general anesthesia if needed due to ongoing pain. Patients will be assessed during hospitalization and at up to 6 weeks after delivery to assess mental health, medical, and quality of recovery outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 or older undergoing non-emergent cesarean delivery with primary neuraxial (epidural, spinal, or CSE) anesthesia. Eligible patients will be those who report severe pain during surgery, defined as pain that does not resolve with 2 trials of first-line pharmacologic therapies (e.g., epidural supplementation with local anesthetics; intravenous opioid analgesics).\n\nExclusion Criteria:\n\n* We will exclude patients who require induction of general anesthesia prior to umbilical cord clamping and by clinician determination.'}, 'identificationModule': {'nctId': 'NCT07334418', 'acronym': 'EAGLET-CS', 'briefTitle': 'Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'EAGLET-CS Pilot: Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study', 'orgStudyIdInfo': {'id': '859498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia', 'description': 'Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement.', 'interventionNames': ['Drug: General anesthetic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous sedation', 'description': 'Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists.', 'interventionNames': ['Drug: Intravenous anesthetic']}], 'interventions': [{'name': 'General anesthetic', 'type': 'DRUG', 'description': 'standard of care general anesthesia', 'armGroupLabels': ['General anesthesia']}, {'name': 'Intravenous anesthetic', 'type': 'DRUG', 'description': 'standard of care intravenous anesthesia', 'armGroupLabels': ['Intravenous sedation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mark Neuman, MD', 'role': 'CONTACT', 'email': 'eagletadmin@pennmedicine.upenn.edu', 'phone': '215-746-7468'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark Neuman', 'investigatorAffiliation': 'University of Pennsylvania'}}}}